MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 MARATHON; CATHETER, CONTINUOUS FLUSH

Model Number 105-5056

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported the physician information could not be provided due to restriction by privacy regulations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that an abnormality was noted on the behavior of the catheter and guidewire under fluoroscopy while the catheter was being delivered to the target lesion.After being retrieved, it seemed the guidewire came out from the proximal part of the tip of the catheter.After the inside of the catheter was flushed, it was confirmed that the catheter was perforated in the proximal part of the distal tip.There hadn't been any resistance when passing the guidewire through, and there was no damage observed to the guidewire.Replacement products were used to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and it was reported there was no patient involvement associated with the event.Ancillary devices include a shuttle sheath 5f, tenrou10 guidewire.

• Brand Name: MARATHON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10714837
• MDR Text Key: 213047724
• Report Number: 2029214-2020-01041
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2023
• Device Model Number: 105-5056
• Device Catalogue Number: 105-5056
• Device Lot Number: B007732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 10/21/2020
• Date Device Manufactured: 04/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1